Analysis Supports Tryton Device in Bifurcations With Large Side Branches

September 30, 2015—Tryton Medical, Inc. announced that results of a post hoc analysis of the pivotal Tryton Randomized Clinical Trial (RCT) have been published online ahead of print by Philippe Généreux, MD, et al in Catheterization and Cardiovascular Interventions (CCI).

The Tryton RCT study evaluated the use of the dedicated Tryton side branch stent compared with provisional stenting in the intended treatment population of patients with a coronary bifurcation lesion in vessels ≥ 2.25 mm in diameter, as determined by quantitative coronary angiography (QCA).

The study investigators, led by Martin B. Leon, MD, concluded that treatment with the Tryton side branch stent showed reductions in target vessel failure and improved side branch percent diameter stenosis in the population of patients with lesions involving side branches that were ≥ 2.25 mm in diameter. Both the Tryton side branch stent and provisional treatment strategies were shown to have similarly low rates of stent thrombosis and no cardiac deaths were reported at 9 months.

For the primary endpoint in this post hoc analysis of 289 patients, the investigators found that target vessel failure was numerically lower in the Tryton group compared to the provisional group. The Tryton device demonstrated a statistically significant lower side branch percent diameter stenosis at 9-month follow-up compared with the provisional group (30.4% vs 40.6%; P = .004). In addition, the Tryton side branch stent reduced the need for additional side branch bailout stenting compared with the provisional approach (0.7% vs 5.6%; P = .02). There was no significant difference in the rate of binary restenosis, reported the company.

In Tryton’s announcement, Dr. Leon commented, “Coronary bifurcation lesions present a number of challenges for interventional cardiologists because each patient can present with varying vessel sizes and there is a wide range of angulations between the main vessel and side branch. For the treatment of bifurcation lesions involving significant side branches, this analysis of the pivotal Tryton RCT provides strong support for the safety and efficacy of the Tryton side branch stent compared with a provisional stenting strategy.” Dr. Leon is Director of the Center for Interventional Vascular Therapy at Columbia University Medical Center, New York-Presbyterian Hospital in New York, New York.

The Tryton side branch stent system features the company's Tri-Zone technology to offer a dedicated strategy for treating bifurcation lesions. The Tryton cobalt chromium stent is deployed in the side branch artery using a standard single-wire, balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel. 

Additionally, the company advised that enrollment was completed in the Tryton Confirmatory Study, a single-arm study of the dedicated stent. The study is designed to confirm results from the pivotal Tryton RCT study in the intended population of patients with coronary bifurcation lesions involving side branches ≥ 2.25 mm in diameter. Findings from this study are expected to be presented at TCT 2015, the 27th annual Transcatheter Cardiovascular Therapeutics scientific session taking place October 11–15, in San Francisco, California.